Amendment 6- SF 30 NCS Vanguard 2 0.pdf

OMB No 0990-0115

1. CONTRACT ID CODE PAGE OF PAGES

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT N/A 1 3

2. AMENDMENT/MODIFICATION NO. 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQ. NO. 5. PROJECT NO. (If applicable)

06 (six) See block 16C, below N/A N/A

6. ISSUED BY CODE N/A 7. ADMINISTERED BY (If other than Item 6)

CODE N/A

National Institutes of Health The Eunice Kennedy Shriver National Institute of Child Health and Human Development Contracts Management Branch, Office of Acquisitions 6100 Executive Blvd., Room 7A-07, MSC 7510 Bethesda, MD 20892-7510

8. NAME AND ADDRESS OF CONTRACTOR (No. Street, County, State and ZIP: Code) () 9A. AMENDMENT OF SOLICITATION NO.

TO ALL PROSPECTIVE OFFERORS

NIH-NICHD-NCS-2012-14

9B. DATED (SEE ITEM 11)

May 17, 2012

10A. MODIFICATION OF CONTRACT/ORDER NO.

10B. DATED (SEE ITEM 13)

CODE FACILITY CODE

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers is extended, is not extended.

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

(a) By completing Items 8 and 15, and returning one (1) copy of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATA SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and data specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

() A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET

FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor is not, is required to sign this document and return copy to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

PURPOSE: To amend RFP NIH-NICHD-NCS-2012-14 and to provide responses to questions received regarding this

RFP.

See the amendment continuation pages.

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print) 16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

Fred Ettehadieh Contracting Officer, OA,NICHD, NIH, DHHS

15B. CONTRACTOR/OFFEROR 15C. DATE SIGNED 16B. UNITED STATES OF AMERICA 16C. DATE SIGNED

(Signature of person authorized to sign)

BY __________________/S/_____________________

(Signature of Contracting Officer)

06/19/2012

NSN 7540-01-152-8070 30-105 STANDARD FORM 30 (REV. 10-83)

PREVIOUS EDITION UNUSABLE Computer Generated Prescribed by GSA

FAR (48 CFR) 53.243

RFP NIH-NICHD-NCS-2012-14

Amendment No. 06 (six) CONTINUATION PAGES

Responses to Questions Received Regarding this RFP (Numbering format continued as it appears on previous Amendments)

1. Contractual Questions

1.9 Question (as appeared in Amendment No. 04): Attachment 3, 1.1.1. a, page 4, states “Earned

Value Management (EVM) will include Monitoring, Reporting, and Site Visits.” Is there a specific requirement for an EVM system, as defined in a specific FAR reference, for this solicitation? Or can the principal of EVMS be applied without full FAR-defined EVMS implementation?

Response (revised from the response in Amendment No. 04): The requirement for EVM is deleted from this solicitation.

Therefore, the solicitation is amended as a result of the above change:

Solicitation PART III-LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS, Section J- List of Attachments is amended as follows:

• Attachment 3, Statement of Work and Reporting Requirements and Deliverables –IDIQ

Contract, Paragraph II, Technical Requirements, is amended as follows:

Page 4, subparagraph 1.1.1, Project Management Plan (PMP), item b, Earned Value Management will include, Monitoring, Reporting, and Site Visits, is deleted. Therefore, subparagraph 1.1.1 is amended to read as follows:

The Contractor shall develop a PMP for review and approval by the COR. The PMP shall include the following:

a) A schedule that incorporates tasks, subtasks, milestones, relationships, estimated task durations, proposed points of contact and resource allocations to tasks;

b) An outline of procedures for critical areas, such as project management, project organization, schedule and budget adherence, regulatory compliance, reporting requirements, staffing and staff retention, modification and addition of protocols, their implementation, support and coordination;

c) The identification of potential problems, consequences of problems and delays, and possible alternatives to resolve the problems or delays with minimal disruption of schedule or cost;

d) Documentation delineating the decision response process in working with the COR, the NICHD Chief Information Officer (CIO), the NICHD Office of Acquisitions Management, and any subcontractors to schedule and implement required tasks; as well as maintaining communication with any other contractors designated by the NICHD;

e) Documentation outlining the lines of communication among Contractor/subcontractor personnel within the larger ROC organization, within the local Study Location, and across ROCs (as applicable), and through what channels communication will flow outside of the organization; and

f) Any mechanism(s) for troubleshooting, quality control and implementation of corrective action plan as needed.

The Contractor shall maintain up-to-date project management records in a searchable, retrievable format of all activities performed throughout the contract period of performance. The format(s) used shall be non-proprietary, open architecture, and preferably, open source. Exceptions to open source must be approved in writing by the Contracting Officer (CO). These records shall provide sufficient depth and understanding of all project activities to meet the transparency requirements of Office of Management and Budget (OMB) and NIH Quality Information Guidelines (http://ospa.od.nih.gov/infoquality/).

http://ospa.od.nih.gov/infoquality/

RFP NIH-NICHD-NCS-2012-14

Amendment No. 06 (six) CONTINUATION PAGES

• Attachment 24, Contract Performance Reports (EVM) is deleted.

The following Attachment is renumbered as a result of the above change:

Attachment 25: Conference Expense Offset Worksheets is renumbered to read Attachment 24.

1.31 Question: In order to participate in future formative research projects, does the institution need to be named on the original proposal?

Response: At present the RFP does not include formative research projects. A prime contractor may subcontract to an institution not named in the original proposal with the consent of the Contracting Officer.

1.32 Question: Solicitation Article H.32 (Use of Funds for Conferences, Meetings and Food) -- This article prohibits use of contract funds to conduct meetings or conferences, yet IDIQ SOW requires contractor to plan for and execute meetings, workshops and/or trainings in support of NCS scientific and operational development. Please explain.

Response: Solicitation Article H.32 does not prohibit use of contract funds to conduct meetings or conferences. Instead it requires prior written Contacting Officer’s approval.

1.33 Question: Does the solicitation Article H.32 prohibit use of contract funds to purchase food for meals, light refreshments or beverages?

Response: No food may be purchased with contract funds because of current Department of

Health and Human Services Efficient Spending Policy.

5. Protocol Questions

5.31 Question: What is the schedule for participant remuneration for the budget?

Response: For budgeting purposes budget for up to $75.00 for each visit.

5.32 Question: In IDIQ Contract SOW, Attachment 3, p. 19, 4.2.1, the RFP states “… a Regional

Operating Center (ROC) may choose to setup and maintain a mobile clinic to conduct Study visits... Note that the Contractor shall still be required to collect environmental samples from participants’ residences …" Also in IDIQ Contract SOW, Attachment 3, p. 20, 4.2.3, it goes on to describe biological specimens. In Task Order 2 SOW, Attachment 3, p. 10, 1.8.1, it includes "(f) Other medical tests, such as measurement of pulmonary function …" What additional specimens, samples, and tests are anticipated as this will impact staff costs, training, equipment, and participant burden? In this same section, see item "(g) Medical record abstraction." Note that medical record abstraction requires qualified, trained staff to abstract the data.

Response: For planning and budgeting purposes assume a uniform cost of $200,000.00 per Regional Operating Center (ROC) per year for all other medical tests such as pulmonary function testing referred to in Task Order 2 SOW, Attachment 3, p. 10, 1.8.1, item(f).